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Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

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ClinicalTrials.gov Identifier: NCT01448525
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.

Condition or disease Intervention/treatment Phase
Hypotrichosis Drug: bimatoprost ophthalmic solution 0.03% Drug: bimatoprost vehicle solution Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
 Drug: bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Other Name: LATISSE®
Placebo Comparator: bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
 Drug: bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall [ Time Frame: Week 16 ]
    Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.


Secondary Outcome Measures :
  1. Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score [ Time Frame: Baseline, Week 16 ]
    The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have inadequate eyelashes
  • Never used prescription eyelash growth products

Exclusion Criteria:

  • No visible eyelashes
  • Permanent eyeliner or eyelash implants
  • Semi-permanent eyelash tint, dye, or extensions within 3 months
  • Over-the-counter eyelash growth products within 6 months
  • Any disease, infection or abnormality of the eye or area around the eye
  • Eye surgery within 3 months, or the anticipated need for eye surgery during the study
  • Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448525


Locations
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United States, Florida
Coral Gables, Florida, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01448525    
Other Study ID Numbers: GMA-LTS-11-002
First Posted: October 7, 2011    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
 Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents